Clinical Safety Scientist I
JOB PURPOSE / SUMMARY:
The Clinical Safety Scientist I is responsible for managing serious adverse
events (SAEs) in clinical trials or post-marketing programs, focusing on all
aspects of the collection, processing, evaluating and reporting of cases in
accordance with CTI’s Global Drug Safety and Pharmacovigilance processes,
International Council for Harmonisation (ICH) guidelines, Good Clinical
Practices (GCP), applicable regulatory guidelines and study procedures. This
individual will track cases from receipt to closure, perform verification of
safety data, and will utilize clinical / pharmacovigilance judgment in coding
of serious events and synthesizing complex clinical information into accurate
and complete narratives.
*Please note that this position is an office based role and we are looking
to fill the position in our Covington, KY or Raleigh, NC office locations.*
What You’ll Do
* Assist with Interfacing between sponsors, vendors, and other departments in the area of safety and pharmacovigilance. Includes assisting with development of project-specific process documents such as Safety Management Plans, Project-Specific Operating Procedures (PSOPS), and/or guidelines as agreed to by CTI and sponsors.
* Process serious adverse events (SAEs) according to Standard Operating Procedures (SOPs) and project specific safety plans.
* Triage SAEs, evaluates SAE data for completeness, and regulatory reportability
* Enter relevant safety data into safety database
* Perform coding of SAEs, medical history, concomitant medications and diagnostic tests
* Develop case narrative utilizing medical records, SAE report forms, Case Report Forms (CRFs), or other relevant documentation.
* Perform quality review of entered data
* Discern what information is required for a complete case and corresponds with site personnel and/or Clinical Research Associate (CRA) to obtain all documentation and resolve inconsistencies
* Participate in generation of reports to the sponsor, regulatory authorities, or vendor to ensure timely reporting of expedited reports
* Participate in reporting expedited safety reports to appropriate regulatory authorities
* Coordinate with data management staff concerning reconciliation of safety data between the clinical and safety databases
* Assist with ensuring safety issues are promptly communicated to appropriate agencies, team members, and sponsors.
* Assist with conducting periodic internal reviews of safety systems, files, and study related documentation including organization and oversight of quality control (QC) and quality assurance (QA) review of all safety related projects in preparation for agency submission and inclusion of narratives into a clinical study report (CSR).
* Assist with developing reports and safety communications as required by various sponsors.
What You Bring
* Bachelor of Science (or equivalent), or RN, Pharm D
* 1 – 2 years of relevant work experience
* Prior GCP Training required
* We support career progression – 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
* We value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
* We value our people – We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade
* Our culture is unparalleled – Click here to learn more about “The CTI Way”
* We think globally and act locally – We have a global philanthropic program supporting our team’s efforts to improve their local communities (Click here to learn more about our “CTI Cares” program)
* We are looking toward the future – We have had a consistent 15% growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate
* Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market